Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-07-27EMA Authorised: Macitentan AccordPharma (macitentan) — Accord Healthcare
Macitentan AccordPharma has been authorized for use, with the therapeutic areas listed as hypertension and pulmonary disease.
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EMA approval · 2026-06-11EMA Authorised: Winrevair — Merck Sharp & Dohme B.V.
Winrevair has been authorised by EMA, with therapeutic area listed as Hypertension and Pulmonary; orphan medicine designation.
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EMA approval · 2026-06-05EMA Authorised: Opsumit (macitentan) — Janssen-Cilag International N.V.
Opsumit (macitentan) has been authorised in the EU for pulmonary arterial hypertension as a new therapeutic option.
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EMA approval · 2026-04-23EMA Authorised: Opsumit (macitentan) — Janssen-Cilag International N.V.
EMA authorised Opsumit (macitentan) by Janssen-Cilag International N.V. for pulmonary arterial hypertension. This marks EU authorization of …
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EMA approval · 2026-04-22EMA Authorised: Volibris (ambrisentan) — GlaxoSmithKline Trading Services Limited
EMA authorised Volibris (ambrisentan) for pulmonary arterial hypertension; the marketing authorisation holder is GlaxoSmithKline Trading Ser…
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FDA approval · 2026-04-14FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Bosentan from Actavis Pharma, Inc. The document indicates approval of a supplemental filing for …
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FDA approval · 2026-04-14FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Bosentan filed by Zydus Pharmaceuticals USA Inc.
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FDA approval · 2026-04-03FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for Tyvaso (treprostinil) by United Therapeutics Corporation.
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EMA approval · 2026-04-01EMA Authorised: Winrevair (sotatercept) — Merck Sharp & Dohme B.V.
The European Medicines Agency authorised Winrevair (sotatercept) from Merck Sharp & Dohme B.V. for pulmonary arterial hypertension and desig…
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FDA approval · 2026-04-01FDA Approved: BOSENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for bosentan submitted by Sun Pharmaceutical Industries, Inc.
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FDA approval · 2026-03-25FDA Approved: WINREVAIR — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for WINREVAIR (sotatercept-CSRK) from Merck Sharp & Dohme LLC, updating the product labeling.
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FDA approval · 2026-03-03FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Bosentan submitted by Zydus Pharmaceuticals USA Inc. under ANDA207760. The approval pertains to …
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FDA approval · 2026-03-03FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for TRACLEER (bosentan) submitted by Actelion Pharmaceuticals US, Inc., resulting in changes to the …
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FDA approval · 2026-03-03FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for TRACLEER (bosentan) submitted by Actelion Pharmaceuticals US, Inc.
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FDA approval · 2026-03-03FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA approves a supplemental application for Bosentan by Actavis Pharma, Inc., allowing the referenced product to be marketed in its generic …
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FDA approval · 2026-03-03FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for bosentan from Zydus Pharmaceuticals USA Inc., typically indicating a labeling or formulation…
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EMA approval · 2026-02-19EMA Authorised: Uptravi (selexipag) — Janssen Cilag International NV
The European Medicines Agency authorised Uptravi (selexipag) from Janssen Cilag International NV for pulmonary arterial hypertension.
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FDA approval · 2026-02-17FDA Approved: AMBRISENTAN — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for ambrisentan (Actavis Pharma, Inc.), a drug used to treat pulmonary arterial hypertension. Th…
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FDA approval · 2026-02-17FDA Approved: AMBRISENTAN — Supplemental Application (Sigmapharm Laboratories, LLC)
FDA approved a supplemental application for Ambrisentan submitted by Sigmapharm Laboratories, LLC.
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FDA approval · 2026-02-17FDA Approved: BOSENTAN — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved Zydus Pharmaceuticals USA Inc.'s original application for Bosentan, indicating approval of a generic bosentan product.
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EMA approval · 2026-02-05EMA Authorised: Yuvanci (macitentan;tadalafil) — Janssen-Cilag International NV
The EMA authorised Yuvanci, a fixed-dose combination of macitentan and tadalafil, for pulmonary arterial hypertension.
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EMA approval · 2026-01-27EMA Authorised: Adcirca (previously Tadalafil Lilly) (tadalafil) — Eli Lilly Nederland B.V.
EU marketing authorisation granted for Adcirca (tadalafil) to treat pulmonary arterial hypertension; the marketing authorisation holder is E…
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FDA approval · 2026-01-18FDA Approved: AMBRISENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for ambrisentan submitted by Sun Pharmaceutical Industries, Inc. This marks an approved modifica…
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EMA approval · 2026-01-06EMA Authorised: Talmanco (previously Tadalafil Generics) (tadalafil) — Viatris Limited
Talmanco has been authorised in the EU as a generic tadalafil product with indications in hypertension and pulmonary arterial hypertension, …
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FDA approval · 2025-12-29FDA Approved: EPOPROSTENOL — Original Application (Gland Pharma Limited)
FDA approved Gland Pharma Limited's epoprostenol under Original Application (ANDA 219237). The drug is indicated for the treatment of pulmon…